FDA Drug recall D-1370-2019
Diphenhist Oral Solution (Diphenhydramine HCl, USP), 12.5 mg/5 mL, a) 4 FL. oz. (118 mL) bottle, NDC: 0536-0770-97, b) One Pint (473 mL) bo…
- FDA Drug
- Class II
- terminated
- Published 2019-06-19
On 2019-06-19 the FDA classified a Class II recall of Diphenhist Oral Solution (Diphenhydramine HCl, USP), 12.5 mg/5 mL, a) 4 FL. oz. (118 mL) bottle, NDC: 0536-0770-97, b) One Pint (473 mL) bo… by Torrent Pharma, citing cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1370-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-05-21 |
| Published | 2019-06-19 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Torrent Pharma |
| Distribution | US |
Product
Diphenhist Oral Solution (Diphenhydramine HCl, USP), 12.5 mg/5 mL, a) 4 FL. oz. (118 mL) bottle, NDC: 0536-0770-97, b) One Pint (473 mL) bottle., NDC: 0536-0770-85, Distributed by Rugby Laboratories, Livonia, MI 48152.
Reason
cGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Identifiers
| code_info | Lot #s: a) 17H025, Exp. 08/2019; 17M022, Exp. 12/2019; 18E011, Exp. 05/2020; 18G018, Exp. 07/2020; 18J014, Exp. 09/2020…Lot #s: a) 17H025, Exp. 08/2019; 17M022, Exp. 12/2019; 18E011, Exp. 05/2020; 18G018, Exp. 07/2020; 18J014, Exp. 09/2020. b) 17E010; 17E030, Exp. 05/2019; 17F013, Exp. 06/2019; 17F010, Exp. 07/2019; 17J014, Exp. 09/2019; 17L005, Exp. 11/2019; 17M017, Exp. 12/2019; 18A022, Exp. 01/2020; 18B021, Exp. 02/2020 18D017, Exp. 04/2020; 18E011, Exp. 05/2020; 18F041, Exp. 06/2020; 18G021; 18H022; 18H028; 18H030, Exp. 08/2020. |
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Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1370-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.